本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(23)02893-3

摘要内容如下：

背景

弱视是儿童期最常见的视力损害，是一个公共卫生问题。几个国家的临床指南建议在修补前延长光学治疗时间。本研究的目的是在一项随机对照试验中比较有无延长光学治疗（EOT）的强化修补方案。

方法

EUPATCH是一项随机对照试验，在英国、希腊、奥地利、德国和瑞士的30家医院进行。新发现的、未经治疗的弱视（定义为两眼之间的差异≥0.30最小分辨角[logMAR]最佳矫正视力[BCVA]的对数）的3-8岁儿童符合条件，弱视是由于屈光参差、斜视或两者兼有。通过计算机生成的序列，参与者被随机（1:1）分配到EOT组（戴眼镜前戴眼镜18周）或早期戴眼镜组（戴眼镜前戴眼镜3周），根据弱视的类型和严重程度进行分层。所有参与者最初都接受了强化贴片疗法（10小时/天，每周6天），并辅以激励材料。补片期长达24周。参与者、父母或监护人、评估者和试验统计员对治疗分配不知情。主要结果是在12周的修补后成功治疗（即，BCVA的≤0.20 logMAR眼间差异）。进行了两个主要分析：主要分析包括所有参与者，包括那些退出的参与者，但排除了那些在第12周没有提供结果数据并继续研究的参与者；另一项分析估算了这一缺失数据。对所有符合条件和随机分配的参与者进行不良事件评估。该研究已在国际标准随机对照试验注册中心（ISRCTN51712593）注册，不再招募。

调查结果

在2013年6月20日至2020年3月12日期间，在排除了8名经详细筛选后发现不合格的参与者后，我们随机分配了334名参与者（170名为EOT组，164名为早期补片组），其中包括188名（56%）男孩，146名（44%）女孩和2名（1%）未记录性别的参与者。对317名参与者（158名在EOT组，159名在早期补片组）的主要结果进行了分析，但未估算缺失数据（EOT组的中位随访时间为42周[IQR 42]，早期补片组为27周[27]）。EOT组170名参与者中的24名（14%）和早期补片组164名参与者中的10名（6%）被排除或退出研究，主要是由于失访和撤回同意书；EOT组中有10人（6%）和早期补片组中有3人（2%）错过了为期12周的访视，但仍留在研究中。早期补片组的参与者成功治疗的比例（159人中的107[67%]）高于EOT组（158人中的86[54%]；13%的差异；修补12周后，P=0.019）。未发生与干预措施相关的严重不良事件。

解释

该试验的结果表明，对于大多数弱视儿童的治疗，早期修补比EOT更有效。我们的研究结果也为弱视治疗的个性化提供了数据。

英文原文如下：

Abstracts

BACKGROUND  Amblyopia, the most common visual impairment of childhood, is a public health concern. An extended period of optical treatment before patching is recommended by the clinical guidelines of several countries. The aim of this study was to compare an intensive patching regimen, with and without extended optical treatment (EOT), in a randomised controlled trial.

METHODS  EuPatch was a randomised controlled trial conducted in 30 hospitals in the UK, Greece, Austria, Germany, and Switzerland. Children aged 3-8 years with newly detected, untreated amblyopia (defined as an interocular difference ≥0·30 logarithm of the minimum angle of resolution [logMAR] best corrected visual acuity [BCVA]) due to anisometropia, strabismus, or both were eligible. Participants were randomly assigned (1:1) via a computer-generated sequence to either the EOT group (18 weeks of glasses use before patching) or to the early patching group (3 weeks of glasses use before patching), stratified for type and severity of amblyopia. All participants were initially prescribed an intensive patching regimen (10 h/day, 6 days per week), supplemented with motivational materials. The patching period was up to 24 weeks. Participants, parents or guardians, assessors, and the trial statistician were not masked to treatment allocation. The primary outcome was successful treatment (ie, ≤0·20 logMAR interocular difference in BCVA) after 12 weeks of patching. Two primary analyses were conducted: the main analysis included all participants, including those who dropped out, but excluded those who did not provide outcome data at week 12 and remained on the study; the other analysis imputed this missing data. All eligible and randomly assigned participants were assessed for adverse events. This study is registered with the International Standard Randomised Controlled Trial Number registry (ISRCTN51712593) and is no longer recruiting.

FINDINGS  Between June 20, 2013, and March 12, 2020, after exclusion of eight participants found ineligible after detailed screening, we randomly assigned 334 participants (170 to the EOT group and 164 to the early patching group), including 188 (56%) boys, 146 (44%) girls, and two (1%) participants whose sex was not recorded. 317 participants (158 in the EOT group and 159 in the early patching group) were analysed for the primary outcome without imputation of missing data (median follow-up time 42 weeks [IQR 42] in the EOT group vs 27 weeks [27] in the early patching group). 24 (14%) of 170 participants in the EOT group and ten (6%) of 164 in the early patching group were excluded or dropped out of the study, mostly due to loss to follow-up and withdrawal of consent; ten (6%) in the EOT group and three (2%) in the early patching group missed the 12 week visit but remained on the study. A higher proportion of participants in the early patching group had successful treatment (107 [67%] of 159) than those in the EOT group (86 [54%] of 158; 13% difference; p=0·019) after 12 weeks of patching. No serious adverse events related to the interventions occurred.

INTERPRETATION  The results from this trial indicate that early patching is more effective than EOT for the treatment of most children with amblyopia. Our findings also provide data for the personalisation of amblyopia treatments.

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